Use Cautiously in: Hepatic impairment (dose ↓ recommended);Patients with reproductive potential (effective contraception is recommended); Pediatric: Safe and effective use in children <18 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

dizziness (most frequent)

fatigue (most frequent)

headache (most frequent)

Ear, Eye, Nose, Throat

tinnitus

Respiratory

cough (most frequent)

Cardiovascular

chest pain

fluid retention

pericarditis

prolonged QT interval

Gastrointestinal

abdominal pain (most frequent)

↓ appetite (most frequent)

diarrhea (most frequent)

nausea (most frequent)

vomiting (most frequent)

dysgeusia

gastritis

GI bleeding

hepatic toxicity

pancreatitis

Dermatologic

itching (most frequent)

rash (most frequent)

acne

Fluid and Electrolyte

dehydration

hyperkalemia

Hematologic

anemia (most frequent)

neutropenia (most frequent)

thrombocytopenia (most frequent)

Musculoskeletal

arthralgia (most frequent)

back pain (most frequent)

myalgia

Miscellaneous

allergic reactions including anaphlaxis

fever (most frequent)

Interactions

Drug-Drug interaction

Concurrent use of moderate to strong CYP3A4 inibitors including amprenavir, aprepitant, atazanavir, bocepravir, ciprofloxacin, clarithromycin, conivaptan, crizotinib, darunavir, digoxin, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posiconazole, ritonavr, saquinavir, telaprevir, telithromcyin, verapamil and voriconazole ↑ blood levels and risk of toxicity and should be avoided.Concurrent use with CYP3A4 inducers including bosentan, carbamazepine, efavirenz, etravirine, modafinil, nafcillin, phenobarbital, phenytoin, rifabutin and rifampin may ↓ blood levels and beneficial effects and should be avoided.Proton pump inhibitors (PPIs) including esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole may ↓ blood levels and effectiveness and should be avoided, consider using short-acting antacids or histamine-H2 receptor blockers instead (these should be taken 2 hr before or 2 hr after bosutinib).May ↑ digoxin levels.Concurrent use with St. John's wort may ↓ blood levels and beneficial effects and should be avoided.Grapefruit juice may ↑ blood levels and the risk of toxicity and should be avoided.

Route/Dosage

Oral (Adults) 500 mg once daily, if complete hematologic response has not occurred by 8 wk, or complete cytologic response by 12 wk or there has been no occurrence of ≥Grade 3 adverse reactions, consider dose increase to 600 mg once daily. Dose adjustments should be made for toxicity (hematologic and non-hematologic).

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)

Implementation

Oral: Administer once daily with food. In patients who do not reach complete hematological response by week 8 or a complete cytogenetic response by week 12, who did not have Grade 3 or higher adverse reactions, and who are currently taking 500 mg daily, consider dose escalation to 600 mg once daily with food. Swallow tablets whole; do not crush, break or chew. Do not handle crushed or broken tablets.

Patient/Family Teaching

Instruct patient to take bosutinib as directed. Take missed doses as soon as remembered if within 12 hours, if longer than 12 hrs skip dose and take usual prescribed dose on the following day. Do not stop taking bosutinib without consulting health care professional. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.

Advise patient to avoid grapefruit and grapefruit juice during therapy.

Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.

Caution female patient to use effective contraception during and for at least 30 days following discontinuation of therapy. Advise patient to avoid pregnancy and breastfeeding; notify health care professional immediately if pregnancy is suspected.

Some of the strategies used to overcome these resistance phenomena such as administration of high doses which is associated with higher toxicity, alternative ABL inhibitors such as Dasatinib, Nilotinib, Bosutinib, and second generation kinase inhibitors with agents that are active against the T3151 mutants, are listed.

announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the conditional marketing authorization of bosutinib in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

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